MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482318550
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that during rod insertion the tulip of the screw splayed when a blocker was inserted into the screw tulip.It was further reported that the blocker was not cross threaded.The screw and blocker were left implanted.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Event or Problem Description
It was reported that during rod insertion the tulip of the screw splayed when a blocker was inserted into the screw tulip.It was further reported that the blocker was not cross threaded.The screw and blocker were left implanted.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported that the construct started at level l2, left side.Screw was not inserted at a difficult angle.Bone quality of the patient was reported to be very soft.Customer was using the persuader when the issue occurred.Excess force was not applied.Screw was inspected briefly by sales representative and a scrub nurse prior to insertion.No damage or other defects were observed at that time.No damage to surrounding bone/tissues was reported.Device sgt was reviewed and the following was found relevant: "the xia 3 spinal system uses the xia buttress thread blocker as its closure mechanism.The titanium blocker is laser etched to more clearly differentiate it from other materials.The blocker is assembled onto the universal tightener for insertion.The universal tightener is available in three different options; standard, short, and double-ended.Note: the xia 3 universal tightener is not to be used for final tightening.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening." since the product was not returned, the root cause could not be determined conclusively.Possible root causes may be over tightening of blocker during final tightening, not using torque wrench, and/or tightening of blocker onto rod that is not properly bent to fit in screw heads.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12276025
• Report Number: 3005525032-2021-00035
• Device Sequence Number: 2839756
• Product Code: NKB
• UDI-Device Identifier: 04546540598608
• UDI-Public: 04546540598608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 482318550
• Device Catalogue Number: 482318550
• Device Lot Number: B91562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female